Pixclara (floretyrosine F 18) is filed as Diagnostic radiopharmaceutical. The sections below restate public label fields stored for this profile.
PIXCLARA is indicated for use with positron emission tomography (PET) to differentiate recurrent or progressive glioma from treatment-related change, in conjunction with other diagnostic evaluations, in adults and pediatric patients 1… PIXCLARA is a radioactive diagnostic drug indicated for use with positron emission tomography (PET) to differentiate recurrent or progressive glioma from treatment-related change, in conjunction with other diagnostic evaluations, in adults…
Floretyrosine F 18 is a radiolabeled derivative of tyrosine and a substrate for the Large Neutral Amino Acid Transporter 1 and 2 (LAT).
Risk for Misinterpretation: Image misinterpretation may occur. • Radiation Risks: Ensure safe drug handling to protect patients and healthcare providers from unintentional radiation exposure. • Image misinterpretation may occur with PIXCLARA PET. • Interpret PIXCLARA PET findings with caution and correlate results with other available diagnostic evaluations, such as histopathology, cross-sectional imaging, and clinical history, to support appropriate clinical decision-making. • PIXCLARA contributes to a patient's overall long-term cumulative radiation exposure.
4 CONTRAINDICATIONS None None ( 4 )
Headache (≥0.5%)
6 ADVERSE REACTIONS The most commonly reported adverse reaction (incidence ≥0.5%) was headache. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Telix Pharmaceuticals at 1-844-455-8638 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of PIXCLARA was evaluated in 382 patients with gliomas. Among these 382 patients, 371 adult patients received at least one intravenous dose of PIXCLARA at a mean activity of 204 ± 18 MBq (5.5 ± 0.47 mCi). The remaining 11 pediatric patients received at least one intravenous dose of PIXCLARA at a mean activity of 155 ± 53.5 MBq (4.2 ± 1.4 mCi). The mean age of the patients was 57 years (range: 5 years to 86 years). Sex was 59% male, 37% female, and 3% unreported. Distribution by race was 26% White, 6% Asian, <1% Black or African American, and 67% other or unreported. Distribution by ethnicity was 3% Hispanic/Latino, 96% non-Hispanic/Latino, and <1% unknown or unreported. Adverse reactions that occurred in ≥0.5% of patients receiving PIXCLARA were headache (0.5%). Adverse reactions that occurred in <0.5% of patients were nausea, injection site reaction, fatigue, and malaise. Adverse Reactions in Pediatric Patients Overall, the safety profile observed in pediatric patients from the clinical study was consistent with the safety profile in adult patients [see Use in Specific Populations (8.4) and Clinical Studies (14) ] .
Adults: 185 MBq to 259 MBq (5 mCi to 7 mCi) as a bolus intravenous injection. • Pediatric Patients 1 Month of Age and Older: 3 MBq/kg actual body weight (0.081 mCi/kg) with a minimum and maximum activity of 14 MBq (0.38 mCi) and 259 MBq (7 mCi), respectively, as a bolus intravenous injection. • Fast for at least 4 hours prior to administration. • Encourage patients to drink water during the fasting period and after administration, and to void, if possible, immediately prior to imaging and frequently after imaging. • Acquire images 20 minutes to 30 minutes after administration for a duration of 20 minutes. • See full prescribing information for additional patient preparation, administration, imaging, interpretation, and radiation dosimetry information.
17 PATIENT COUNSELING INFORMATION Radiation Risks Advise patients of the radiation risks with PIXCLARA. Instruct patients to drink a sufficient amount of water to ensure adequate hydration before their PET study and urge them to drink and urinate frequently following the administration of PIXCLARA to reduce radiation exposure [see Dosage and Administration (2.3) and Warnings and Precautions (5.2) ] . Fasting Instruct patients to not eat for at least 4 hours prior to injection of PIXCLARA [see Dosage and Administration (2.3) ] . Pregnancy Inform pregnant women of the risk of fetal exposure to radiation doses if they undergo a radionuclide procedure with PIXCLARA [see Use in Specific Populations (8.1) ] . Lactation Advise a lactating woman to temporarily discontinue breastfeeding and to pump and discard breast milk for a minimum of 4 hours after PIXCLARA administration to minimize radiation exposure to the breastfed infant [see Use in Specific Populations (8.2) ] .
According to its FDA label, Pixclara (floretyrosine F 18) is approved for: PIXCLARA is indicated for use with positron emission tomography (PET) to differentiate recurrent or progressive glioma from treatment-related change, in conjunction with other diagnostic evaluations, in adults and pediatric patients 1…. PIXCLARA is a radioactive diagnostic drug i… For medical advice, please talk to your prescriber or pharmacist.
Pixclara (floretyrosine F 18) belongs to the Diagnostic radiopharmaceutical class of medications.
The FDA label lists Pixclara (floretyrosine F 18) as: 3 DOSAGE FORMS AND STRENGTHS Injection: 185 MBq/mL to 11,100 MBq/mL (5 mCi/mL to 300 mCi/mL) of floretyrosine F 18 in approximately 15 mL at the end of synthesis (EOS) as a clear, colorless to slightly yellow solution in a multiple-dose vial. Injection: 185 MBq/mL to 11,100 MBq/mL (5 mCi/mL to 300 mCi/mL) of floretyrosine F 18 in approximately 15 mL at end of synthesis (EOS) in a multiple-dose vial. ( 3 ); intravenous route. Available strengths and packaging vary by manufacturer.
Not yet. As of the most recent FDA data we ingest, no A-rated generic equivalent is listed for Pixclara. Availability changes as patents expire.
Our ingest of the FDA label for Pixclara (floretyrosine F 18) does not include a Boxed Warning at this time. See the full label on DailyMed for the current, authoritative version.
The FDA Enforcement Report does not show an active/ongoing recall for Pixclara (floretyrosine F 18) in our latest ingest. Recall data can change daily — verify at FDA.gov.
The FDA record lists the approval date for Pixclara (floretyrosine F 18) as 2026-09-11.
The FDA label lists Telix Pharmaceuticals US Inc. as a labeler/manufacturer of Pixclara (floretyrosine F 18). Multiple firms may market generics of the same molecule.
The FDA label states: "Store PIXCLARA at 15°C to 25°C (59°F to 77°F) upright in the original container with radiation shielding. • Use PIXCLARA within 14 hours from the time of the end of synthesis. • Dispose of any unused drug in accordance w…" Follow the packaging insert for the authoritative guidance.
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